Conduct Phase III CT: CDSCO Panel Tells Sun Pharma on FDC Relugolix plus Estradiol plus Norethindrone Acetate Tablets
New Delhi: Citing that there is no safety and efficacy data on Indian population, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major Sun Pharma to conduct the Phase III clinical trial of the fixed-dose combination (FDC) drug Relugolix plus Estradiol plus Norethindrone Acetate Tablets.
This came after the drug major Sun Pharma presented its proposal for a Phase-III clinical trial waiver for the grant of permission to manufacture and market FDC of Relugolix, Estradiol, and Norethindrone Acetate Tablets (40 mg + 1 mg + 0.5 mg) along with the bioequivalance (BE) study report.
The combination of Relugolix, estradiol, and norethindrone is used to manage heavy menstrual bleeding caused by uterine leiomyomas (fibroids) in premenopausal women.
Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions.
Relugolix is used in men to treat advanced prostate cancer. Relugolix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It helps treat prostate cancer by lowering the amount of testosterone hormone in the blood. In some patients, testosterone will cause prostate cancer to grow larger.
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